Edwards PASCAL CLASP IID/IIF Pivotal Clinical Trial
Condition(s) studied
Investigational drug(s) / intervention(s)
Edwards PASCAL System: Transcatheter mitral valve repair with the Edwards PASCAL System
Abbott Mitraclip System: Transcatheter mitral valve repair with the Abbott Mitraclip System
Study summary
To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Valve Repair System in patients with degenerative mitral regurgitation (DMR) who have been determined to be at prohibitive risk for mitral valve surgery by the Heart Team, and in patients with functional mitral regurgitation (FMR) on guideline directed medical therapy (GDMT)
Eligibility
Primary outcome measure(s)
- PASCAL is not inferior to MitraClip with respect to the proportion of patients with major adverse events (MAE). The primary safety endpoint is a composite of Major Adverse Events (MAEs). — 30 days.
- PASCAL is not inferior to Mitraclip with respect to the proportion of patients with MR severity reduction as measured by echocardiography using a scale of 0-4+ for the CLASP IID Cohort. — 6 months
- PASCAL is not inferior to Mitraclip with respect to the time to first heart failure hospitalization or death for the CLASP IIF Cohort only. — From date of randomization until date of first heart failure hospitalization or death, through 5 year follow-up
Trial sites (81)
| Facility | City | Region | Status |
|---|---|---|---|
| Banner University Medical Center | Phoenix | Arizona | |
| TMC Healthcare | Tucson | Arizona | |
| Scripps Memorial Hospital La Jolla | La Jolla | California | |
| Cedars Sinai Medical Center | Los Angeles | California | |
| UC Irvine | Orange | California | |
| Sutter Medical Center-Sacramento | Sacramento | California | |
| Kaiser Permanente San Francisco | San Francisco | California | |
| University of California, San Francisco | San Francisco | California | |
| Stanford University | Stanford | California | |
| Los Robles Hospital and Medical Center | Thousand Oaks | California | |
| Medical Center of the Rockies | Loveland | Colorado | |
| Medstar Washington Hospital Center | Washington D.C. | District of Columbia | |
| The Cardiac and Vascular Institute Research Foundation | Gainesville | Florida | |
| Mount Sinai | Miami Beach | Florida | |
| NCH Rooney Heart Institute | Naples | Florida | |
| AdventHealth Orlando | Orlando | Florida | |
| Piedmont Healthcare | Atlanta | Georgia | |
| Emory University Hospital and Emory University Hospital Midtown | Atlanta | Georgia | |
| Northwestern University | Chicago | Illinois | |
| St. Vincent Heart Center | Carmel | Indiana | |
| University of Iowa Hospitals & Clinics | Iowa City | Iowa | |
| Massachusetts General Hospital | Boston | Massachusetts | |
| Brigham and Woman's Hospital | Boston | Massachusetts | |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | |
| University of Michigan | Ann Arbor | Michigan | |
| Henry Ford Hospital | Detroit | Michigan | |
| Mayo Clinic | Rochester | Minnesota | |
| St.Luke's Hospital of Kansas City | Kansas City | Missouri | |
| Washington University/Barnes Jewish Hospital | St Louis | Missouri | |
| Morristown Medical Center | Morristown | New Jersey | |
| Rutgers-RWJMS | New Brunswick | New Jersey | |
| Albany Medical College | Albany | New York | |
| State University of New York at Buffalo | Buffalo | New York | |
| NYU Langone Hospital - Long Island | Mineola | New York | |
| NYU Langone Health | New York | New York | |
| Columbia University Medical Center/New York Presbyterian Hospital | New York | New York | |
| Lenox Hill Hospital and North Shore University | New York | New York | |
| Rochester General Hospital | Rochester | New York | |
| Montefiore Medical Center | The Bronx | New York | |
| The Christ Hospital | Cincinnati | Ohio |
+ 41 more sites — see the full list on the official registry below.
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Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03706833 on ClinicalTrials.gov ↗ ← All trials in the USA